PCI Pharma Services · 1 week ago
QC Specialist II, Analytical Investigations
Bedford, NH
Full-time
Onsite
Entry, Mid Level
2+ years expPCI Pharma Services is a leader in providing life-changing therapies with a global impact. The QC Specialist II will lead investigations into quality control analytical deviations and serve as a key point of contact during audits, ensuring compliance and timely responses.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Lead investigations into QC Analytical deviations, OOS/OOT/OOE results, and other quality issues
Serve as a key point of contact during audits and inspections, ensuring timely and compliant responses
Draft and revise change controls, technical reports, cGMP documents, and protocols
Perform QC analytical testing, review data, and identify trends to proactively address risks
Assist in managing analytical equipment to maintain compliance and efficiency
Collaborate cross-functionally to close out quality events and audit findings on time
Help shape and refine QC processes that support continuous improvement
Qualification
Required
Bachelor's degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field
2–5 years of QC Analytical Chemistry experience (pharma experience preferred)
Hands-on experience with UPLC, HPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Densitometer, and Osmometer
Solid understanding of cGMP, ICH, USP, and global compendia guidelines, especially in analytical method validation and stability studies
Strong organizational and documentation skills
Technical writing ability
Excellent communication skills (written and verbal)
Ability to thrive in a fast-paced, dynamic environment, juggling multiple priorities while maintaining a sharp eye for detail
Proficiency in MS Office
Experience with lab-based data management systems a plus
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase